Patient Satisfaction and Postoperative Outcomes Following All-on-Four Implant Surgery Under Analgosedation: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patient Reported postoperative pain andswelling
研究概览
简要总结
Objective: To evaluate patient satisfaction, postoperative pain, inflammatory re-sponse, and analgesic consumption following All-on-Four implant surgery performed under analgosedation.
Methods: This prospective clinical study will include 30 adult patients classified as ASA physical status I-II who were scheduled for elective full-arch rehabilitation using the All-on-Four protocol under analgosedation. Patients with contraindications to sedation, cognitive impairment, or emergency indications will be excluded. Postoperative pain and swelling will be assessed using a visual analogue scale (VAS) up to 72 hours. Real analgesic consumption will be recorded during the first three postoperative days. Systemic inflammatory response will be evaluated by serum C-reactive protein (CRP) levels measured preoperatively and on postoperative day 3. Patient experience with anesthetic management will be assessed using a structured questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective full-arch implant rehabilitation
- •ASA physical status I or II
- •Ability to understand the study procedures and provide written informed consent
排除标准
- •Emergency dental or surgical intervention
- •Pregnancy
- •Patients with cognitive impairment or psychiatric conditions affecting reliable outcome reporting
- •Patients with contraindications to analgo-sedation
研究组 & 干预措施
Analgosedation
Adult patients classified as ASA physical status I-II who were scheduled for elective full-arch rehabilitation using the All-on-Four protocol under analgosedation
干预措施: Full arch rehabilitation with four dental implants (Procedure)
结局指标
主要结局
Patient Reported postoperative pain andswelling
时间窗: "From enrollment to the end of treatment at 3 days"
The primary outcome measures included patient-reported postoperative pain and swelling, analgesic use and systemic inflammatory response. Postoperative pain intensity and swelling were assessed using a 10-point Visual Analogue Scale (VAS), where 0 indicated the absence of symptoms and 10 indicated the maximum perceived severity. Assessments were performed preoperatively and at 2, 6, 12, 24, 48, and 72 hours postoperatively.
Rescue analgesic consumption
时间窗: From surgery up to 3rd postoperative day
Rescue analgesic consumption was recorded for each patient during the first three postoperative days and quantified based on the total number of tablets consumed and daily dose. Analgesic intake was used as an indirect indicator of postoperative discomfort.
The systemic inflammatory response
时间窗: "From enrollment to the end of treatment at 3 days"
To evaluate the systemic inflammatory response, serum C-reactive protein (CRP) levels were measured preoperatively and on postoperative day 3 using standard laboratory procedures.
次要结局
- Patient experience with analgosedation("From enrollment to the end of treatment at 3 days")
研究者
Igor Smojver
Sinior assistant at Department of Oral Surgery
University of Zagreb